N/A
N=90
Types of Fixation in Arthroscopic Rotator Cuff Repair
Rotator Cuff Tear
Bottom Line
View on ClinicalTrials.gov: NCT00508183 ↗Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2018
Primary outcome: Primary: Western Ontario Rotator Cuff Index (WORC) — 84.4; 81.7 units on a scale — p=0.60
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- single row (Procedure); double row fixation (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Ottawa Hospital Research Institute
- Primary completion
- Jul 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Western Ontario Rotator Cuff Index (WORC) |
84.4; 81.7 | 0.60 |
| SECONDARY Constant Score |
85.6; 86.3 | 0.05 |
| SECONDARY ASES Score |
87.9; 89.3 | 0.05 |
| SECONDARY Strength Test |
8.0; 7.3 | — |
| SECONDARY Healing Rate |
67; 78 | 0.05 |
Summary
The study will identify if there is a difference of quality of life after surgery between two techniques used in surgery. The two different techniques are either the Single Row Fixation or the Double Row Fixation.
Eligibility Criteria
Inclusion Criteria
- Patients who have failed standard non-surgical management of their rotator cuff tear, and who would benefit from a surgical repair of the cuff.
- Imaging and intra-operative findings confirming a full thickness tear of the rotator cuff.
Exclusion Criteria
- Characteristics of the cuff tear that render the cuff irrepairable.
- Significant shoulder comorbidities
- Previous surgery on affected shoulder
- Patients with active workers compensation claims
- Active joint or systemic infection
- Significant muscle paralysis
- Rotatorcuff tear arthropathy
- Charcots arthropathy
- Major medical illness
- Unable to speak or read English
- Psychiatric illness that precludes informed consent
Data sourced from ClinicalTrials.gov (NCT00508183). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.